Bow spring driven suction valve for an endoscope

This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/490,130 filed on Mar. 14, 2023, the disclosure of which is incorporated herein by reference.

This disclosure relates generally to valve assemblies and methods, and particularly to suction valve assemblies and methods for an endoscope.

A wide variety of intracorporeal medical devices and systems have been developed for medical use, for example, for endoscopic procedures. Some of these devices and systems include guidewires, catheters, catheter systems, endoscopic instruments, and the like. These devices and systems are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and systems as well as alternative methods for manufacturing and using medical devices and systems.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices and medical systems. In a first example, a suction valve assembly for a medical device can comprise a valve body having a valve well, an inlet channel in fluid communication with the valve well, and an outlet channel in fluid communication with the valve well; and a bow spring configured to move within the valve well, comprising a central arc having inner and outer sides, such that the bow spring, when flexed, moves the central arc towards the outer side, a valve stem attached to the inner side of the central arc of the bow spring. The bow spring can be positioned with the inner surface of the central arc facing the inlet channel of the valve body such that the bow spring, when unflexed, presses the stem into the inlet channel to close the valve. The bow spring, when flexed, can pull the stem away from the inlet channel to open the valve.

Alternatively or additionally to any of the examples above, the suction valve assembly can further include a cap accessible from outside the valve body, the cap in mechanical communication with the bow spring such that actuating the cap flexes the bow spring and releasing the cap unflexes the bow spring.

Alternatively or additionally to any of the examples above, the cap comprises a projection extending into the valve well in contact with the bow spring.

Alternatively or additionally to any of the examples above, the valve well extends the length of the longest dimension of the valve body between a top face and an opposing bottom face of the valve body, and the inlet and outlet channels are positioned in side surfaces of the valve well.

Alternatively or additionally to any of the examples above, the valve well comprises a curved wall and a flat wall each extending between a top face and an opposing bottom face of the valve body, and one or more of the bow spring and the cap comprise a shaped portion abutting at least the flat wall to prevent rotation within the valve body.

Alternatively or additionally to any of the examples above, a top anchor of the bow spring and a bottom anchor of the bow spring are each shaped portions of the bow spring abutting the flat wall of the valve well to prevent rotation of the bow spring within the valve body.

Alternatively or additionally to any of the examples above, a flange of the cap is a shaped portion of the cap abutting the flat wall of the valve well to prevent rotation of the flange within the valve well.

Alternatively or additionally to any of the examples above, the suction valve assembly further includes a circumferential seal disposed about the valve stem that presses against the inlet opening when the valve is closed.

Alternatively or additionally to any of the examples above, the main body further comprises a collar at an upper opening of the valve well; and the cap further comprises a clip in contact with the collar of the main body when the valve is in a closed position.

Alternatively or additionally to any of the examples above, the bow spring further comprises an anchor having an inclined bottom surface, and the valve well further comprises an inclined floor surface mirroring the shape and angle of the inclined bottom surface of the bow spring anchor such that the inclined bottom surface and the inclined floor surface meet within the valve well.

Alternatively or additionally to any of the examples above, the main body comprises a single piece of uniform material.

Alternatively or additionally to any of the examples above, the cap comprises a single piece of uniform material.

Alternatively or additionally to any of the examples above, the bow spring comprises a single piece of uniform material.

Alternatively or additionally to any of the examples above, the cap, the main body, and the bow spring are made of polyethylene plastic.

In another example, an endoscopic surgical device comprises an endoscopic probe, a suction valve assembly according to any of the examples above, and a source of suction in fluid communication with the inlet channel of the suction valve assembly, such that opening the valve provides suction to the endoscopic probe from the inlet channel, through the valve well, and into the outlet channel. The outlet passage of the suction valve assembly is in fluid communication with the endoscopic probe.

In another example, a suction valve assembly can be for use in an endoscope having a lumen configured to extend into a patient's body cavity. The suction valve assembly comprises a valve body having a valve well, an inlet channel in fluid communication with the valve well, and an outlet channel in fluid communication with the valve well; and a bow spring configured to move within the valve well, comprising a central arc having inner and outer sides, such that the bow spring, when flexed, moves the central arc towards the outer side, a valve stem attached to the inner side of the central arc of the bow spring. The bow spring is positioned with the inner surface of the central arc facing the inlet channel of the valve body such that the bow spring, when unflexed, presses the stem into the inlet channel to close the valve. The bow spring, when flexed, pulls the stem away from the inlet channel to open the valve.

These and other features and advantages of the present disclosure will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

This disclosure is now described with reference to an illustrative medical system that may be used in endoscopic medical procedures. However, it should be noted that reference to this particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed devices and related methods of use may be utilized in any suitable procedure, medical or otherwise. This disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (e.g., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. It is to be noted that in order to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary. For simplicity and clarity purposes, not all elements of the disclosure are necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and/or all of the components for which there are more than one, unless explicitly stated to the contrary. Additionally, not all instances of some elements or features may be shown in each figure for clarity.

It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect the particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangeable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and/or claims to name and/or differentiate between various described and/or claimed features. It is to be understood that the numerical nomenclature is not intended to be limiting and is illustrative only. In some embodiments, alterations of and deviations from previously-used numerical nomenclature may be made in the interest of brevity and clarity. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc. or may be omitted entirely, and/or a different feature may be referred to as the “first” element. The meaning and/or designation in each instance will be apparent to the skilled practitioner.

The detailed description is intended to illustrate but not limit the disclosure Those skilled in the art will recognize that the various elements described may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description illustrates example embodiments of the disclosure.

1 FIG. 2 FIG. 100 200 100 100 a With reference to, an illustrative endoscopeis depicted anddepicts an illustrative endoscope system. The endoscopemay include an elongated tube or shaftthat is configured to be inserted into a subject (e.g., a patient).

205 200 100 100 100 100 205 210 210 215 210 b b A light sourceof the endoscope systemmay feed illumination light to a distal portionof the endoscope. The distal portionof the endoscopemay house an imager (e.g., CCD or CMOS imager) (not shown). The light source(e.g., lamp) may be located in a video processing unitthat processes signals input from the imager and outputs processed video signals to a video monitor (not shown) for viewing. The video processing unitmay also serve as a component of an air/water feed circuit by housing a pressurizing pump, such as an air feed pump, in the unit.

100 100 100 100 105 100 105 100 100 100 100 220 225 100 230 235 100 100 100 235 100 110 115 100 120 110 a c b a c c d c d a d c a The endoscope shaftmay include a distal tip(e.g., a distal tip unit) provided at the distal portionof the shaftand a flexible bending portionproximal to the distal tip. The flexible bending portionmay include an articulation joint (not shown) to assist with steering the distal tip. On an end faceof the distal tipof the endoscopeis a gas/lens wash nozzlefor supplying gas to insufflate the interior of the patient at the treatment area and for supplying water to wash a lens covering the imager. An irrigation openingin the end facesupplies irrigation fluid to the treatment area of the patient. Illumination windows (not shown) that convey illumination light to the treatment area, and an openingto a working channelextending along the shaftfor passing tools to the treatment area, may also be included on the faceof the distal tip. The working channelmay extend along the shaftto a proximal channel openingpositioned distal to an operating handle(e.g., a proximal handle) of the endoscope. A biopsy valvemay be utilized to seal the channel openingagainst unwanted fluid egress.

115 125 105 130 210 115 The operating handlemay be provided with knobsfor providing remote 4-way steering of the distal tip via wires connected to the articulation joint in the bendable flexible portion(e.g., one knob controls up-down steering and another knob control for left-right steering). A plurality of video switchesfor remotely operating the video processing unitmay be arranged on a proximal end side of the handle.

115 135 135 140 240 245 140 100 100 220 a a a c 2 FIG. The handlemay be provided with dual valve locations. One of the valve locationsmay receive a gas/water valvefor operating an insufflating gas and lens water feed operation. A gas supply lineand a lens wash supply linerun distally from the gas/water valvealong the shaftand converge at the distal tipproximal to the gas/wash nozzle().

135 145 250 145 100 235 100 a a The other valve locationmay receive a suction valvefor operating a suction operation. A suction supply linemay run distally from the suction valvealong the shaftto a junction point in fluid communication with the working channelof the endoscope.

115 210 260 265 260 240 245 250 255 265 210 205 260 100 100 100 265 210 215 240 260 2 b b b b a c b The operating handlemay be electrically and fluidly connected to the video processing unit, via a flexible umbilicaland connector portionextending therebetween. The flexible umbilicalhas a gas (e.g., air or CO) feed line, a lens wash feed line, a suction feed line, an irrigation feed line, a light guide (not shown), and an electrical signal cable (not shown). The connector portionwhen plugged into the video processing unitconnects the light sourcein the video processing unit with the light guide. The light guide runs along the umbilicaland the length of the endoscope shaftto transmit light to the distal tipof the endoscope. The connector portionwhen plugged into the video processing unitalso connects the air pumpto the gas feed linein the umbilical.

270 100 265 260 240 275 280 270 285 290 265 240 260 265 240 290 215 245 270 280 270 290 240 265 265 293 255 260 270 245 265 295 250 250 260 100 c b c c c b c b a A water reservoir or container(e.g., water bottle) may be fluidly connected to the endoscopethrough the connector portionand the umbilical. A length of gas supply tubingpasses from one end positioned in an air gapbetween the top(e.g., bottle cap) of the reservoirand the remaining waterin the reservoir to a detachable gas/lens wash connectionon the outside of the connector portion. The gas feed linefrom the umbilicalbranches in the connector portionto fluidly communicate with the gas supply tubingat the detachable gas/lens wash connection, as well as the air pump. A length of lens wash tubing, with one end positioned at the bottom of the reservoir, may pass through the topof the reservoirto the same detachable connectionas the gas supply tubingon the connector portion. In other embodiments, the connections may be separate and/or separated from each other. The connector portionmay also have a detachable irrigation connectionfor irrigation supply tubing (not shown) running from a source of irrigation water (not shown) to the irrigation feed linein the umbilical. In some embodiments, irrigation water is supplied via a pump (e.g., peristaltic pump) from a water source independent (not shown) from the water reservoir. In other embodiments, the irrigation supply tubing and lens wash tubingmay source water from the same reservoir. The connector portionmay also include a detachable suction connectionfor suction feed lineand suction supply linefluidly connecting a vacuum source (e.g., hospital house suction) (not shown) to the umbilicaland endoscope.

240 245 135 140 100 100 250 135 145 145 235 100 b b c b The gas feed lineand lens wash feed linemay be fluidly connected to the valve locationfor the gas/water valveand configured such that operation of the gas/water valve in the well controls supply of gas or lens wash to the distal tipof the endoscope. The suction feed lineis fluidly connected to the valve locationfor the suction valveand configured such that operation of the suction valvein the well controls suction applied to the working channelof the endoscope.

145 235 145 235 145 235 145 145 145 145 235 295 235 145 145 235 The suction valvemay be configured to allow or prevent suction and/or a suction effect in the working channel. When the suction valveis in a valve closed position (e.g., a first configuration), a suction fluid flow through the working channelmay be blocked by the suction valve. When suction is desired in the working channel, an operator or user may actuate the suction valve(e.g., by depressing a button on the valve and/or actuating the suction valvein one or more other suitable manners) in order to bring the suction valveto a valve open position (e.g., a second configuration). When the suction valveis in the valve opened position, a flow channel inside the suction valve may connect the working channelto the suction device coupled to suction connectionand the suction device may create a negative pressure that draws fluid into and out of the working channelthrough an outlet provided in the suction valve. When the operator or user releases the suction valve, the valvemay return to its valve closed position and reduce or block a suction fluid flow from the working channel.

145 200 260 100 260 145 145 235 145 145 145 145 145 235 145 145 In some cases, suction valvesmay rely on a path of least resistance to direct suction fluid flow through the endoscope system. In some cases, when a suction pump is turned on for a procedure, the pump remains on for an entirety of the procedure and continually pulls air from the flexible umbilical, which in turn draws fluid from the line side of the endoscopethat runs up the umbilicusand connects to a port at the suction valve. When the suction valveis in a first position and/or configuration (e.g., a closed position) the suction force or negative pressure from the suction pump is blocked from the working channeland may pull fluid from atmosphere through the suction valve. When the suction valveis actuated to a second position and/or configuration (e.g., an opened position) (e.g., when the button or cap associated with the suction valveis depressed and/or actuated in one or more other suitable manners), the opening from atmosphere through the suction valveto the suction pump may be effectively closed or blocked by the suction valveand a fluid path between working channeland the suction pump through the suction valvemay be opened. Thus, fluid moving to the suction pump may follow a path of least resistance, where the path may change depending on whether the suction valveis in a first position (e.g., a closed position) or a second position (e.g., an opened position)

145 100 145 235 235 In some cases, valve stems of suction valvesmay be configured to have a close fit with a valve well configured to receive the valve stem in the endoscope. In such suction valves, when the valve stem is in a first position the close fit blocks a flow path or increases a resistance to flow between the working channeland the suction pump and reduces a resistance to flow between atmosphere and the suction pump. Similarly, when the valve stem is in a second position, the close fit blocks a flow path or increases a resistance to flow between the atmosphere and the suction pump and reduces a resistance to flow between the working channeland the suction pump.

145 Suction valvesconfigured to block flow using close fits between the valve stem and valve well requires valves stems that are precisely manufactured. The precision required to produce suction valves with close fits requires expensive materials (e.g., metals, etc.), highly precise machinery, and is time consuming to achieve.

145 145 235 235 145 235 235 235 235 145 235 145 235 145 235 Additionally, suction valveswith close fit valve stems and valve wells are manufactured to have at least some clearance to allow the valve stem to adjust positions within the valve well. This clearance, may result in leakage during use, which may lead to two issues noticeable by a physician. The first is when the suction valveis in a position intended to block suction from the working channel, there is still some suction flow passing through the working channeland the suction valveto the suction pump. The smaller the clearance between the valve stem and the valve well, the less unwanted flow through the working channelthat occurs and the larger the clearance, the more unwanted flow through the working channel, however, clearance is needed to facilitate movement of the valve stem within the valve well. When flow is actively moving up the working channelin such configurations of the suction valve, users may perceive the suction as “poor insufflation” due to the suction of the suction pump pulling volume from a body lumen in which the user is working, even when the suction valveis in a position intended to block a suction flow from the working channel. Second, when a valve stem of the suction valveis in a position within a valve well to facilitate a suction flow between the working channeland the suction pump through the suction valve, the flow from atmosphere to the suction pump may not be completely blocked. Any such leaking from atmosphere may reduce a pressure differential between suction valve and the distal end of the working channel, which leads to a reduced suction force or negative pressure, reduced flow rates, and aerated flow through the fluid path to the suction pump.

145 145 145 Suction valvesconfigured to operate with close-fit valve stems and valve wells may work well enough when intended for re-use in multiple procedures, as a price point for such suction valves can be high enough to justify manufacturing the suction valvesfrom materials and with the necessary precision that can achieve and maintain desired tolerances over the life of the reusable suction valves. However, a price point of a single use suction valve may not allow for use of the necessary materials, tools, and/or precise manufacturing required to achieve and/or maintain tolerances over the life of single-use suction valves.

100 145 300 3 3 FIGS.A andB The suction valve configurations for endoscopesand/or other suitable scopes discussed herein address the above-noted concerns with existing suction valves and are configured to mitigate and/or eliminate leakage along an unintended flow path through the suction valve.depict a schematic perspective view of an illustrative suction valveconfigured to address these concerns.

3 3 FIGS.A andB 300 302 310 320 310 320 302 310 As shown in, the suction valveincludes a cap, a main body, and a bow spring. The main bodyhouses the bow spring, which is in mechanical communication with the capseated above and inserted into the main body.

310 312 313 314 316 310 302 318 314 320 The main bodydefines an inlet channel, an outlet channel, and a valve well. A collarat the top of the main bodyinterfaces with the cap. A floor surfaceat the bottom of the valve wellprovides an anchoring surface for the bow spring.

302 303 300 304 314 310 306 320 308 310 302 The caphas a broad button surfacethat is pressed by a user to actuate the valve, a flangethat fits within the valve wellof the main body, a projectionthat interfaces with the bow spring, and a clipthat further interfaces with the main bodyto secure the cap.

320 322 323 324 324 324 326 324 324 322 322 306 324 318 310 a b b a The bow springhas top and bottom anchorsand, a central arcwith an outer surfaceand an inner surface, and a valve stemon the inner surfaceof the arc. The top anchorhas a recessto receive the projectionof the cap, while the bottom surface of the bottom anchoris shaped to contact the floor surfaceof the main body.

4 FIG. 302 308 316 310 326 320 312 300 As shown in, when not being pressed, the capis disposed in an upward position. The clipconnects to the underside of the collarof the main bodyto limit the cap's upward movement. The valve stemof the bow springis disposed within the inlet channel, which is in fluid communication with the source of suction. The valve stem's position means that the valveis closed and suction will not be applied at the end of the endoscopic probe.

326 326 312 326 326 312 326 300 a a a As shown, a seal ringattached to the valve stemmay interface with the walls of the inlet channelto assure a sufficient seal within the closed valve. The seal ringmay be any appropriate material, such as rubber or flexible plastic, and in some implementations may be significantly more flexible than the materials of the stemand the walls of the channel. One of ordinary skill will recognize that the shape and size of the seal ringmay vary depending on the quality of the seal that is required, the overall resilience needed, and the predicted usage of the valve.

324 320 322 323 323 318 318 310 322 302 The central arcof the bow springis shaped to unflex toward a more lengthened position, pushing against the anchorsand. The bottom anchoris in contact with the floor surface, made of a rigid material so that the floor surfacewill not move relative to the rest of the main body. Instead, the top anchorwill be pushed upwards, biasing the capinto the unpressed position.

5 FIG. 303 302 304 302 314 302 302 316 302 322 324 320 326 312 300 As shown in, when a user presses down on the button surfaceof the cap, the flangeof the capslides further into the recess of the valve well. When the capis fully pressed downwards, the underside of the capmay be in contact with the top of the collar. The capin turn pushes the top anchorfurther into the valve well, flexing the central arcof the bow spring. This, in turn, unseats the valve stemfrom the inlet channelto open the valve, thus permitting suction through the valve and the attached endoscopic probe.

314 326 312 304 302 322 323 320 314 3 FIG.B The cross section of the valve wellmay be in a variety of shapes, but as shown in, the cross section may be a generally circular profile with one flattened side. One of ordinary skill will recognize that such a shape can restrict rotational freedom of the valve components, thus helping to assure that the valve stemstays aligned with the inlet channel. The flangeof the capand the upper and lower anchors,of the bow springmay all be shaped to fit smoothly within the cross-sectional shape of the valve welland may abut sufficient side surfaces of the well to avoid rotation.

300 302 310 320 326 326 324 320 310 308 302 302 310 326 326 326 a a a The suction valvemay be manufactured of relatively inexpensive materials suitable for disposal after a single use. The cap, main body, and bow spring(excluding the seal) may each be manufactured from a single piece of polyethylene plastic, and the sealmay in turn be manufactured from a single piece of flexible material (plastic, rubber, or the like). Each of the three pieces of plastic may, in some implementations, be made of the same or similar materials, with the thickness and dimensions of each piece chosen to provide the necessary resilience and hardness. For example, the main arcof the bow springmay be thinner than the walls of the main bodyso that the main body stays relatively rigid while the bow spring flexes as described herein. Similarly, some give may be provided in the clipof the capto allow it to snap into place when assembled, while still securing the capto the main bodyin use. The stemmay include a groove or recess sized to accept the sealfitting tightly around the stem. In some cases, the seal and the valve stem may be co-extruded and molded with one or more materials. In other cases, the valve stem may be monolithic such that the body and seals are formed from a single material using molding and/or machining techniques. Components of the valve may be made of other materials. For example, the bow spring may be made of a thin leaf of metal or any appropriately elastic material, and other components may be made of any of a variety of polymers or metals suitable to the functions described herein.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.